← FDA DRUG APPROVALS

FDA NDA · NDA021870

FLUDEOXYGLUCOSE F18

Sponsor: FEINSTEIN

APPLICATION
NDA021870
TYPE
NDA
ORIGINAL APPROVAL
2005-08-19
LATEST ACTION
2023-11-09
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

FLUDEOXYGLUCOSE F18 · ReferencePrescription
FLUDEOXYGLUCOSE F-18 20-400mCi/ML · INJECTABLE · INTRAVENOUS
FLUDEOXYGLUCOSE F18 · ReferenceDiscontinued
FLUDEOXYGLUCOSE F-18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INTRAVENOUS

Approval history

2023-11-09Labeling · Supplement 18 · standard — Letter ↗AP
2019-06-27Labeling · Supplement 15 · standard — Letter ↗AP
2016-08-01Manufacturing (CMC) · Supplement 12AP
2015-09-10Manufacturing (CMC) · Supplement 11AP
2015-07-08Labeling · Supplement 10 · standardAP
2014-12-15Manufacturing (CMC) · Supplement 9 — Letter ↗AP
2012-11-28Manufacturing (CMC) · Supplement 8AP
2012-01-18Labeling · Supplement 7 · standard — Label ↗AP
2011-01-05Labeling · Supplement 5 · unknown — Label ↗AP
2010-08-18Labeling · Supplement 4 · standard — Label ↗AP
2006-12-21Manufacturing (CMC) · Supplement 1AP
2005-08-19Type 5 - New Formulation or New Manufacturer · Original · unknown — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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